The present invention relates to the field of handling hazardous materials, including but not limited to materials such as drugs used for medical purposes. More particularly, this invention relates to a means and method for enabling a user to transfer a hazardous material from a sealed vial or container without allowing significant leakage of the material to the environment. Specific examples of hazardous materials to which the invention is particularly applicable include but are not limited to liquid, freeze dried or powdered cytotoxic drugs that are used extensively in chemotherapy treatment of cancer patients and radiographic materials.
High toxicity materials, including cytotoxic drugs and radiographic materials, are often enclosed in small bottles or vials that have an opening sealed by an elastomeric plug. It is highly desirable to prevent spillage or escape of even minimal amounts of hazardous materials in either liquid or gas form. Small droplets of materials could undesirably contaminate the ambient environment or come in contact with the person administering the substance.
Hazardous drugs are compounded in different ways. In large hospital pharmacies and homecare pharmacies, pharmacy technicians wearing gowns and double gloves compound hazardous drugs under vented biological laboratory hoods. These specially designed hoods are expensive and take up valuable floor space. In hospital wards, clinics, doctors'offices and other locations, laboratory hoods may not be readily available and the personnel compounding the drugs may not usually wear such elaborate protective equipment. Shelf life limitations and patient specific dosing requirements may demand that the drug be mixed closer in time and space to the point of care.
According to one conventional means and method used at the point of care, the user utilizes a sharp needle attached to a syringe to pierce and elastomeric plug or other cap that seals the vial and draw the drug out, often after injecting a suitable solvent or diluents into the vial. The user then injects the drug into a reseal element on an intravenous (IV) container from which the drug is delivered to the patient. Unfortunately, this method creates another hazard in that the person handling the drug or someone else can be “pricked” by the sharp needle.
Therefore, a principal object of this invention is to provide a method and means securing a vial within an impermeable isolation enclosure.
A further object of the invention is to provide a method and means for piercing a vial within the impermeable isolation enclosure in a fixed position; and selectively accessing the contents of the vial.
Another object of the invention is to provide a method and means for safely transferring a portion of the vial contents, while the vial remains pierced within an impermeable isolation enclosure.
These and other objects will be apparent to those skilled in the art.